Stricken language would be deleted from and underlined language would be added to present law.
1 State of Arkansas As Engrossed: S3/10/11 S3/24/11
2 88th General Assembly A Bill
3 Regular Session, 2011 SENATE BILL 840
4
5 By: Senator Irvin
6
7 For An Act To Be Entitled
8 AN ACT TO CREATE THE ABORTION-INDUCING DRUGS SAFETY
9 ACT; AND FOR OTHER PURPOSES.
10
11
12 Subtitle
13 THE ABORTION-INDUCING DRUGS SAFETY ACT.
14
15
16 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF ARKANSAS:
17
18 SECTION 1. Arkansas Code Title 20, Chapter 16 is amended to add an
19 additional subchapter to read as follows:
20 20-16-1301. Title.
21 This subchapter shall be known and may be cited as the “Abortion-
22 Inducing Drugs Safety Act".
23
24 20-16-1302. Legislative findings — Purpose.
25 (a) The General Assembly finds that:
26 (1) The United States Food and Drug Administration approved the
27 drug mifepristone, a first-generation selective progesterone receptor
28 modulator as an abortion-inducing drug with a specific gestation, dosage, and
29 administration protocol;
30 (2)(A) As tested and approved by the United States Food and Drug
31 Administration, and as outlined in the drug label, an abortion by
32 mifepristone consists of three (3) two hundred milligram (200 mg) tablets of
33 mifepristone taken orally followed by two (2) two hundred microgram (200 mcg)
34 tablets of misoprostol taken orally, and is effective for forty-nine (49)
35 days after the first day of the woman’s last menstrual period.
36 (B) The patient is to return for a follow-up visit in
*MGF245* 03-03-2011 12:28:27 MGF245
As Engrossed: S3/10/11 S3/24/11 SB840
1 order to confirm that a complete termination of pregnancy has occurred;
2 (3) The treatment described in subdivision (a)(2) of this
3 section requires three (3) office visits by the patient, and the dosages may
4 only be administered in a clinic, medical office, or hospital and under
5 supervision of a physician;
6 (4) Court testimony by Planned Parenthood and other physicians
7 demonstrates that physicians routinely fail to follow the mifepristone
8 protocol as tested and approved by the United States Food and Drug
9 Administration, and as outlined in the drug label, Planned Parenthood
10 Cincinnati Region v. Taft, 459 F. Supp. 2d 626 (S.D. Oh. 2006);
11 (5) Specifically, Planned Parenthood and other physicians are
12 administering a single oral dose of two hundred milligrams (200 mg) of
13 mifepristone followed by a single vaginal dose of eight-tenths milligrams
14 (8/10 mg) misopristol through sixty-three (63) days after the first day of
15 the woman’s last menstrual period without medical supervision and without
16 follow-up care, Planned Parenthood Cincinnati Region, 459 F. Supp. 2 at
17 630n.7;
18 (6) The use of mifepristone presents significant medical risks
19 to women, including without limitation:
20 (A) C. sordellii bacterial infection;
21 (B) Septic shock;
22 (C) Toxic shock syndrome;
23 (D) Adult respiratory distress syndrome from sepsis;
24 (E) Escheria coli sepsis;
25 (F) Group B Streptococcus septicemia;
26 (G) Disseminated intravascular coagulopathy with hepatic
27 and renal failure;
28 (H) Severe pelvic infection; and
29 (I) Massive hemorrhage;
30 (7)(A) Abortion-inducing drugs are associated with an increased
31 risk of complications relative to surgical abortion.
32 (B) The risk of complications increases with increasing
33 gestational age, and, in the instance of mifepristone, with failure to
34 complete the two-step dosage process;
35 (8)(A) Off-label use of mifepristone can be deadly.
36 (B) As of August 2010, a European drug manufacturer
2 03-03-2011 12:28:27 MGF245
As Engrossed: S3/10/11 S3/24/11 SB840
1 acknowledged at least twenty-nine (29) deaths worldwide related to
2 mifepristone use;
3 (9)(A) Medical studies have indicated that one (1) to two (2)
4 out of every one thousand (1,000) women who undergo mifepristone abortions
5 will require emergency blood transfusion for massive hemorrhage.
6 (B) By May 2006, the United States Food and Drug
7 Administration reported that at least one hundred sixteen (116) women
8 required blood transfusions for massive bleeding after mifepristone
9 abortions, with at least fifty-four (54) losing more than one-half (1/2) of
10 their blood volume; and
11 (10)(A) The absence of proper follow-up care after mifepristone
12 abortions has resulted in at least seventeen (17) women having undetected
13 ectopic pregnancies.
14 (B) Eleven (11) of the undetected ectopic pregnancies
15 resulted in ectopic rupture.
16 (b) Based on the findings in subsection (a) of this section, it is the
17 purpose of this subchapter to:
18 (1) Protect women from the dangerous and potentially deadly off-
19 label use of abortion-inducing drugs, including without limitation,
20 mifepristone; and
21 (2) Ensure that physicians abide by the protocol tested and
22 approved by the United States Food and Drug Administration for abortion-
23 inducing drugs as outlined in the drug labels.
24
25 20-16-1303. Definitions.
26 As used in this subchapter:
27 (1)(A) “Abortion” means the act of using or prescribing any
28 instrument, medicine, drug, or any other substance, device, or means with the
29 intent to terminate the clinically diagnosable pregnancy of a woman with
30 knowledge that the termination by those means will with reasonable likelihood
31 cause the death of the unborn child.
32 (B) An act under subdivision (1)(A) of this section is not
33 an abortion if the act is performed with the intent to:
34 (i) Save the life or preserve the health of an
35 unborn child;
36 (ii) Remove a dead unborn child caused by
3 03-03-2011 12:28:27 MGF245
As Engrossed: S3/10/11 S3/24/11 SB840
1 spontaneous abortion;
2 (iii) Remove an ectopic pregnancy; or
3 (iv) Treat a maternal disease or illness for which
4 the prescribed drug is indicated;
5 (2)(A) “Abortion-inducing drug” means a medicine, drug, or any
6 other substance prescribed or dispensed with the intent of terminating the
7 clinically diagnosable pregnancy of a woman with knowledge that the
8 termination will with reasonable likelihood cause the death of the unborn
9 child.
10 (B) “Abortion-inducing drug” includes off-label use of
11 drugs known to have abortion-inducing properties that are prescribed
12 specifically with the intent of causing an abortion, including without
13 limitation, misoprostol and methotrexate.
14 (C) “Abortion-inducing drug” does not include drugs that
15 may be known to cause an abortion, but that are prescribed for other medical
16 indications such as chemotherapeutic agents, diagnostic drugs, and other
17 similar drugs.
18 (D) Use of drugs under subdivisions (2)(A) and (B) of this
19 section to induce abortion is also known as chemical abortion;
20 (3) "Adverse event" means an undesirable experience associated
21 with the use of a medical product in a patient, including without limitation
22 an event that causes:
23 (A) Death;
24 (B) Threat to life;
25 (C) Hospitalization;
26 (D) Disability or permanent damage;
27 (E) Congenital anomaly or birth defect, or both;
28 (F) Required intervention to prevent permanent impairment
29 or damage;
30 (G) Other serious important medical events, including
31 without limitation:
32 (i) Allergic bronchospasm requiring treatment in an
33 emergency room;
34 (ii) Serious blood dyscrasias;
35 (iii) Seizures or convulsions that do not result in
36 hospitalization; and
4 03-03-2011 12:28:27 MGF245
As Engrossed: S3/10/11 S3/24/11 SB840
1 (iv) The development of drug dependence or drug
2 abuse;
3 (4) “Drug label” or “drug’s label” means the pamphlet
4 accompanying an abortion-inducing drug that outlines the protocol tested and
5 authorized by the United States Food and Drug Administration and agreed upon
6 by the drug company applying for United States Food and Drug Administration
7 authorization of that drug;
8 (5) “Final printing labeling instructions,” means the United
9 States Food and Drug Administration document that delineates how a drug is to
10 be used under United States Food and Drug Administration approval;
11 (6) “Gestational age” means the time that has elapsed since the
12 first day of the woman's last menstrual period;
13 (7) “Mifepristone” means the specific abortion-inducing drug
14 regimen also known as RU-486;
15 (8) “Physician” means a person licensed to practice medicine in
16 this state, including medical doctors and doctors of osteopathy;
17 (9) “Pregnant” or “pregnancy” means that female reproductive
18 condition of having an unborn child in a woman’s uterus; and
19 (10) “Unborn child” means the offspring of human beings from
20 conception until birth.
21
22 20-16-1304. Off-label use of mifepristone prohibited.
23 (a) It is unlawful to knowingly give, sell, dispense, administer,
24 otherwise provide, or prescribe an abortion-inducing drug to a pregnant woman
25 for the purpose of inducing an abortion in that pregnant woman or enabling
26 another person to induce an abortion in a pregnant woman unless the person
27 who gives, sells, dispenses, administers, or otherwise provides or prescribes
28 the abortion-inducing drug is a physician, and the provision or prescription
29 of the abortion-inducing drug satisfies the protocol tested and authorized by
30 the United States Food and Drug Administration and as outlined in the drug
31 label and final printing labeling instructions for the abortion-inducing
32 drug.
33 (b) A physician giving, selling, dispensing, administering, or
34 otherwise providing or prescribing the abortion-inducing drug shall first
35 examine the woman and document in the woman’s medical chart the gestational
36 age and the intrauterine location of the pregnancy before giving, selling,
5 03-03-2011 12:28:27 MGF245
As Engrossed: S3/10/11 S3/24/11 SB840
1 dispensing, administering, or otherwise providing or prescribing the
2 abortion-inducing drug because:
3 (1) The failure and complications from chemical abortion
4 increase with increasing gestational age;
5 (2) The physical symptoms of chemical abortion can be identical
6 to the symptoms of ectopic pregnancy; and
7 (3) Abortion-inducing drugs do not treat ectopic pregnancies but
8 rather are contraindicated in ectopic pregnancies.
9 (c) Every pregnant woman to whom a physician gives, sells, dispenses,
10 administers, otherwise provides, or prescribes an abortion-inducing drug
11 shall be provided with a copy of the drug’s label and final printing labeling
12 instructions.
13
14 20-16-1305. Criminal Penalties.
15 A person who purposely, knowingly, or recklessly violates this
16 subchapter is guilty of a Class A misdemeanor.
17 20-16-1306. Civil Penalties.
18 (a) In addition to whatever remedies are available under the common or
19 statutory law of this state, a violation of this subchapter shall provides a
20 basis for:
21 (1) A civil malpractice action for actual and punitive damages;
22 (2) A professional disciplinary action under the rules of the
23 Arkansas State Medical Board or other appropriate licensing board; and
24 (3) Recovery for the woman’s survivors for the wrongful death of
25 the woman under § 16-62-102.
26 (b) Civil liability shall not be assessed against the pregnant woman
27 upon whom the drug-induced abortion is performed.
28 (c) If requested, a court shall allow a woman to proceed in an action
29 under this section using solely her initials or a pseudonym and may close any
30 proceedings in the case and enter other protective orders to preserve the
31 privacy of the woman upon whom the drug-induced abortion was performed.
32 (d) If judgment is rendered in favor of the plaintiff, the court shall
33 also render judgment for a reasonable attorney’s fee in favor of the
34 plaintiff against the defendant.
35
36 20-16-1307. Construction.
6 03-03-2011 12:28:27 MGF245
As Engrossed: S3/10/11 S3/24/11 SB840
1 (a) This subchapter does not create or recognize a right to abortion.
2 (b) This subchapter is not intended to make lawful an abortion that is
3 currently unlawful.
4
5 20-16-1308. Right of intervention.
6 The General Assembly, by joint resolution, may appoint one (1) or more
7 of its members who sponsored or cosponsored this subchapter to intervene in
8 his or her official capacity as a matter of right in any case in which the
9 constitutionality of this law is challenged.
10
11 /s/Irvin
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
7 03-03-2011 12:28:27 MGF245